System, endovascular graft, aortic aneurysm treatment: medical device reports filed with FDA

72,039 reports carry this product code, 1994–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

72,039
reports with this product code: 0.3% of all MAUDE reports; 3,187
reports, 12 months to August 2026: 3,361 in the 12 months before; 14.8%
classified as malfunction: 62.3% across all reports; 9.8%
classified as death, as reported: 0.9% across all reports

Product code MIH is FDA's classification for "System, endovascular graft, aortic aneurysm treatment" (unknown panel), a class 3 device. 72,039 medical device reports carry this product code, 0.3% of the MAUDE database, from February 1994 to August 2026.

3,187 reports arrived in the 12 months to August 2026, close to the 3,361 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (74.9%), malfunction (14.8%) and death (9.8%). 30 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
GORE EXCLUDER AAA Endoprosthesis	9,583	633	4.8%	7%
Afx	3,583	30	5%	1.9%
Gore Tag Thoracic Endoprosthesis	2,821	4	14.7%	3.3%
Endurant	1,861	0	14.7%	12.4%
Endurant Iis Bifurcated Stent Graft	1,706	121	11.6%	22.3%
Valiant Captivia - FF	1,532	95	15.1%	35.4%
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System	1,473	311	7.7%	12.6%
Endurant Stent Graft	1,471	56	10%	27.3%
Afx2	1,263	123	6.4%	1.1%
Medtronic Aneurx Bifurcated Stent Graft Flexible	1,261	0	9.7%	9.7%
Zenith Flex AAA Endovascular Graft Bifurcated Main Body	1,172	15	6.1%	28.5%
Valiant Navion	1,149	40	17.4%	32.2%
Ancure Endograft System	1,123	0	5.1%	16%
Endurant Abdominal Stent Graft System	997	0	12.9%	11.1%
Afx System	882	0	8.4%	8.3%
Ovation IX	870	45	3.1%	0.7%
Powerlink System	791	0	9.8%	2.3%
TREO Abdominal Stent-Graft System	779	130	3.2%	28.2%
GORE EXCLUDER Conformable AAA Endoprosthesis	757	222	4.8%	19.9%
GORE EXCLUDER Iliac Branch Endoprosthesis	752	158	4%	13.7%
Aneurx	730	0	9.6%	7.8%
Zenith Flex with Spiral-Z Technology AAA Endovascular Graft Iliac Leg	723	91	3.6%	30.1%
Talent Abdominal Stent Graft System - Hydro	719	0	12%	11.7%
Endurant Bifurcated Stent Graft	672	13	13.8%	22.2%
Aortic Excluder Aaa Endoprosthesis C3	667	0	4.2%	9.4%
Talent Thoracic Stent Graft System	588	0	26.7%	9.5%
Valiant Captivia - CW	588	25	16.7%	32.1%
Endurant Iliac Stent Graft	555	11	13%	28.1%
Zenith Aaa Iliac Leg Graft	551	0	1.8%	0.4%
Valiant Stent Graft	525	31	11.6%	26.9%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Ireland	22,015	30.6%
W L Gore & Associates	19,322	26.8%
Endologix	6,885	9.6%
Cook	4,899	6.8%
Medtronic Cardiovascular	3,616	5%
Medtronic Cardiovascular Santa Rosa	2,088	2.9%
Bolton Medical	1,882	2.6%
William Cook Europe	1,630	2.3%
Guidant Endovascular Solutions	1,548	2.1%
Medtronic Ave Peripheral Division	1,096	1.5%
Medtronic Cardiovascular Galway	1,083	1.5%
Medtronic Vascular	867	1.2%
Bard Peripheral Vascular	323	0.4%
Medtronic	60	0.1%
Cordis	58	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death9.8%7,089

Injury74.9%53,993

Malfunction14.8%10,668

Other0.3%197

Not given0.1%92

Who filed

Manufacturer report99%71,307

Voluntary report0.3%250

User facility report0%0

Distributor report0.4%288

Not given0.3%194

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	24,357	33.8%
Insufficient device problem information	4,605	6.4%
Migration or expulsion of device	4,420	6.1%
Occlusion within devicethe device blocked	3,908	5.4%
Malposition of device	2,829	3.9%
Device remains implanted	2,622	3.6%
Patient-device incompatibilitythe device did not suit the patient	2,458	3.4%
Difficult to removethe device was hard to remove	1,849	2.6%
Failure to adhere or bond	1,283	1.8%
Fluid/blood leak	1,264	1.8%
Activation, positioning or separation problem	1,209	1.7%
Kinkedthe tube or line kinked	1,190	1.7%
Material puncture/hole	1,165	1.6%
Difficult to position	1,075	1.5%
Explanted	1,040	1.4%
Migrationthe device moved from where it was placed	1,035	1.4%
Other (for use when an appropriate device code cannot be identified)	1,034	1.4%
Material deformation	997	1.4%
Difficult or delayed positioning	988	1.4%
Inaccurate delivery	944	1.3%

Questions about system, endovascular graft, aortic aneurysm treatment reports

What is product code MIH?

FDA's classification code for "System, endovascular graft, aortic aneurysm treatment", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

72,039 reports through August 2026, 3,187 of them in the latest 12 months.

Which brands appear most often?

GORE EXCLUDER AAA Endoprosthesis (9,583), Afx (3,583), Gore Tag Thoracic Endoprosthesis (2,821), Endurant (1,861) and Endurant Iis Bifurcated Stent Graft (1,706). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.